This public calendar is issued by the Food and Drug Administration. It lists significant meetings held by designated FDA policy makers with persons outside the executive branch of the federal government.

Official Name: Janet Woodcock, M.D., Acting Commissioner

Event Date: 02/23/2021
Location: Teleconference
Subject: COVID-19 Pandemic and Depression
FDA Participant/Group: MELISSA ROBB;
Non FDA Participant/Group: Richard Pops (Alkermes);

Event Date: 02/23/2021
Location: Virtual
Subject: Patient Centered Outcomes Research Institute (PCORI): Selection Committee Meeting
FDA Participant/Group: N/A
Non FDA Participant/Group: Kara Ayers (Cincinnati Children's Hospital Medical Center); Jennifer DeVoe (Oregon Health & Science University); Michael Lauer (National Institutes of Health);

Event Date: 02/24/2021
Location: Virtual
Subject: Association for Accessible Medicines Board of Directors Meeting
FDA Participant/Group: DAYLE CRISTINZIO;
Non FDA Participant/Group: Several members of the board of directors for the Association for Accessible Medicines and its staff

Event Date: 02/25/2021
Location: Virtual
Subject: Penn Orphan Disease Center 10th Anniversary Symposium: A New Era of Rare Disease Diagnostics and Therapeutics
FDA Participant/Group: DAYLE CRISTINZIO;
Non FDA Participant/Group: Industry, government, media, academia and other registered guests

Official Name: Amy Abernethy, M.D., Ph.D., Principal Deputy Commissioner

Event Date: 02/22/2021
Location: Virtual
Subject: Icahn School of Medicine; Speaker: Serious Adverse Events (SAEs) in Clinical Research on Older Adults with Serious Illness
FDA Participant/Group: HARPREET SINGH;
Non FDA Participant/Group: Industry stakeholders

Event Date: 02/23/2021
Location: Virtual
Subject: COVID-19 Evidence Accelerator Therapeutics Lab Meeting
FDA Participant/Group: N/A
Non FDA Participant/Group: Academia, industry, and other stakeholders

Event Date: 02/25/2021
Location: Virtual
Subject: Ax-S Thursday Series on Integrating Clinical Research into Modern Healthcare Delivery; Panelist: Smarter Data Capture in Hybrid Clinical Trials and Access Programs
FDA Participant/Group: N/A
Non FDA Participant/Group: Industry stakeholders

Official Name: Erika Anderson, Acting Deputy Commissioner for Policy, Legislation, and International Affairs

No Significant Event

Official Name: Jim Sigg, Deputy Commissioner for Operations

No Significant Event

Official Name: Frank Yiannas, Deputy Commissioner for Food Policy and Response

No Significant Event

Official Name: Mark Abdoo, Associate Commissioner for Global Policy and Strategy

Event Date: 02/25/2021
Location: Virtual
Subject: Introductory Meeting on International Standards, and Potential for Future Cooperation
FDA Participant/Group: N/A
Non FDA Participant/Group: Kunal Khatri (United Kingdom Department of International Trade);

Official Name: Judy McMeekin, Associate Commissioner for Regulatory Affairs

No Significant Event

Official Name: Heidi Rebello, Acting Associate Commissioner for External Affairs

No Significant Event

Official Name: RADM Denise Hinton, Chief Scientist

No Significant Event

Official Name: Patrizia Cavazzoni, M.D., Acting Director, Center for Drug Evaluation and Research

Event Date: 02/22/2021
Location: Virtual
Subject: Briefing on FDA’s COVID-19 Variants Guidances
FDA Participant/Group: MAREN KAHN; JEFFREY SHUREN; TRISTAN COLONIUS; JULIA TIERNEY; PETER MARKS; ANDREW TANTILLO; KATHERINE KLIMCZAK; JODI SCHIPPER; MICHAEL NGUYEN;
Non FDA Participant/Group: Congressional staffers of the House Energy and Commerce Health Subcommittee; Health, Education, Labor, and Pensions (HELP) Committee; House Agricultural and FDA Approrpriations Subcommittee; and Senate Appropriations Committee

Official Name: Peter Marks, M.D., Ph.D., Director, Center for Biologics Evaluation and Research

Event Date: 02/22/2021
Location: Virtual
Subject: California Institute for Regenerative Medicine Scientific Strategy Advisory Panel Meeting
FDA Participant/Group: N/A
Non FDA Participant/Group: Members of the California Institute for Regenerative Medicine Scientific Strategy Advisory Panel and presenters

Event Date: 02/23/2021
Location: Virtual
Subject: 4th Annual Gene Therapy for Rare Disorders Meeting; Speaker: Keynote - FDA’s Efforts to Enhance Gene Therapy Regulatory Interactions
FDA Participant/Group: N/A
Non FDA Participant/Group: Industry, academia, and other stakeholders

Event Date: 02/23/2021
Location: Virtual
Subject: 4th Annual Gene Therapy for Rare Disorders Meeting; Industry Leaders Panel: Delivering on the Promise of Gene Therapies
FDA Participant/Group: N/A
Non FDA Participant/Group: Industry, academia, and other stakeholders

Event Date: 02/23/2021
Location: Virtual
Subject: 4th Annual Gene Therapy for Rare Disorders Meeting; Panel Discussion: Investigating the Current Global Regulatory Landscape in Light of Recent Approvals
FDA Participant/Group: N/A
Non FDA Participant/Group: Industry, academia, and other stakeholders

Event Date: 02/24/2021
Location: Virtual
Subject: Health on Wednesday; Lunch & Learn Speaker: COVID-19 Vaccines
FDA Participant/Group: N/A
Non FDA Participant/Group: Industry, healthcare advocates, and other stakeholders

Event Date: 02/26/2021
Location: Virtual
Subject: Vaccines and Related Biological Products Advisory Committee Meeting
FDA Participant/Group: N/A
Non FDA Participant/Group: Academia, industry, and other stakeholders

Official Name: Jeffrey Shuren, M.D., J.D., Director, Center for Devices and Radiological Health

Event Date: 02/26/2021
Location: Virutal
Subject: The Indiana Clinical and Translational Sciences Institute Retreat; Speaker: Keynote Address
FDA Participant/Group: MISTI MALONE; KENNETH CAVANAUGH; DOUGLAS KELLY; ANDREW FARB; VINCENT DEVLIN; TIMOTHY STENZEL; RAQUEL PEAT; RONALD JEAN; WILLIAM JUNG; NICOLE IBRAHIM; LAURENCE COYNE;
Non FDA Participant/Group: Industry, academia, and other stakeholders

Official Name: Susan T. Mayne, Ph.D., Director, Center for Food Safety and Applied Nutrition

No Significant Event

Official Name: Mitchell R. Zeller, J.D., Director, Center for Tobacco Products

Event Date: 02/24/2021
Location: Virtual
Subject: Public Health Keynote Plenary: FDA E-Cigarette Regulatory Stances
FDA Participant/Group: N/A
Non FDA Participant/Group: Society for Research on Nicotine & Tobacco 2021 attendees

Official Name: Steven Solomon, Director, Center for Veterinary Medicine

Event Date: 02/26/2021
Location: Webex
Subject: Veterinary Issues of Mutual Interest
FDA Participant/Group: ASHLEY STEEL; NEAL BATALLER; TIMOTHY SCHELL; NADINE STEINBERG; ANTONIA MONIQUE SENNETT; PATRICK MCDERMOTT; SHANNON RUTHERFORD; AMBER MCCOIG; WILLIAM FLYNN; SUSAN BRIGHT-PONTE; ANN NORRIS; MATTHEW LUCIA; CINDY BURNSTEEL; SIOBHAN DELANCEY;
Non FDA Participant/Group: Representatives from The Pew Charitable Trusts

Official Name: William Slikker, Jr., Ph.D., Director, National Center for Toxicological Research

Event Date: 02/25/2021
Location: Virtual
Subject: Arkansas Bioinformatics Consortium Seminar - Data Science Solutions for COVID-19; Speaker: Opening Remarks
FDA Participant/Group: WEIDA TONG;
Non FDA Participant/Group: Government, academia, and other invited guests

Official Name: Mark Raza, J.D., Acting Chief Counsel

No Significant Event